The purpose of this Funding Opportunity Announcement (FOA)
is to invite revisions (formerly called "competing revisions") from
currently funded NCI P01 program projects for early-stage development of
enabling informatics technologies to improve the acquisition, management,
analysis, and dissemination of data and knowledge. As a component of the
NCI's Informatics Technology for Cancer Research (ITCR) Initiative, this FOA
aims to promote interdisciplinary collaboration in the development of innovative
computational methods and informatics approaches that are essential for
cancer research on all fronts to accelerate scientific discovery and
ultimately translate data into knowledge and clinical practice. Applications
that focus on data processing and analysis or mathematical/statistical
modeling alone without new technology development are not appropriate for
this FOA.

Key Dates

Posted Date

August 12, 2013

Open Date (Earliest Submission Date)

October 18, 2013

Letter of Intent Due Date(s)

30 days before the due date.

Application Due Date(s)

November 18, 2013; June 18, 2014; November 18, 2014; June
18, 2015, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.

AIDS Application Due Date(s)

November 18, 2013; June 18, 2014; November 18, 2014; June
18, 2015, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.

NIH’s new Application Submission System & Interface for
Submission Tracking (ASSIST) is available for the electronic preparation and
submission of multi-project applications through Grants.gov to NIH.
Applications to this FOA must be submitted electronically; paper applications
will not be accepted. ASSIST replaces the Grants.gov downloadable forms
currently used with most NIH opportunities and provides many features to enable
electronic multi-project application submission and improve data quality,
including: pre-population of organization and PD/PI data, pre-submission
validation of many agency business rules and the generation of data summaries
in the application image used for review.

Required Application Instructions

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH
Guide for Grants and Contracts) and where instructions in the
Application Guide are directly related to the Grants.gov downloadable forms
currently used with most NIH opportunities. Conformance to all
requirements (both in the Application Guide and the FOA) is required and
strictly enforced. Applicants must read and follow all application instructions
in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific
instructions deviate from those in the Application Guide, follow the
program-specific instructions. Applications that do not comply with
these instructions may be delayed or not accepted for review.

There are several options to submit your application to the agency through Grants.gov. You can use the ASSIST system to prepare, submit and track your application online. You can download an application package from Grants.gov, complete the forms offline, submit the completed forms to Grants.gov and track your application in eRA Commons. Or, you can use other institutional system-to-system solutions to prepare and submit your application to Grants.gov and track your application in eRA Commons.
Learn more.

The purpose of this Funding Opportunity Announcement (FOA)
is to invite revisions (formerly called "competing revisions") from
currently funded NCI P01 program projects for early-stage development of
enabling informatics technologies to improve the acquisition, management,
analysis, and dissemination of data and knowledge. Early-stage development is
defined for the purpose of this FOA as the initial development or the
significant modification of existing tools for new applications. Objectives of
this FOA are 1) to promote integration of informatics technology development
with hypothesis-driven cancer research and translational/clinical
investigations, 2) to promote interdisciplinary collaboration and public-private
partnership in informatics technology development and dissemination, 3) to
promote data and knowledge sharing and the development of informatics tools to
enable data and knowledge sharing, 4) to support initial development of new
software or adapting existing software for new applications, 5) to promote
interaction and collaboration among funded informatics development projects.

Background and Rationale

Over the last decade, major advances in biology coupled with
innovations in information technology led to an explosive growth of biological
and biomedical information. From the genomic revolution and many of its
manifestations to recent development in high-throughput high-content screening,
biomedical scientists have never before been exposed to research data that are
so rich and comprehensive, and yet so massive and complex. This situation
provides unprecedented opportunities for rapid discovery. At the same time, it
confronts researchers, especially bench biologists and clinicians, with significant
challenges to access data, analyze data, and ultimately transform discovery
into new knowledge and clinical practice. These challenges are even more
prominent in the field of cancer research where complexity and heterogeneity of
the disease translate to complex data generation conditions and high data
management and analysis overhead, a condition that creates significant barriers
to knowledge discovery and dissemination.

The fast growing field of biomedical informatics offers
potential solutions to the “big data” problem. At the intersection of biology,
medicine, mathematics, statistics, computer science, and information
technology, biomedical informatics involves the development and application of
computational tools to the organization and understanding of biomedical
information, so that new insight and knowledge can be discerned. There is now
general consensus that biomedical research is transforming into an information
science, and biomedical informatics is no longer an option but an integral component
of all biomedical research. However, there are many challenges to the
realization of broad acceptance and sophisticated adoption of information
technology in everyday research. Some of the challenges are associated with
tools, some are with people. For example, there continues to be the need of
user-friendly software tools and informatics support for bench biologists and
clinical researchers, especially in association with data generated by emerging
high-throughput technologies. In some areas, tool development is disengaged
from potential users, resulting in over-building and lack of usage. Another
significant challenge is in data sharing and data integration. On top of
philosophical and cultural barriers, there are significant technical hurdles.
These include lack of common standards for data collection and data exchange,
lack of common data elements for data harmonization, high overhead for data
storage and dissemination, inadequate tools for annotation, and shortage of
computational expertise in biomedical research in general.

Recently, informatics needs and challenges have become a
frequent topic of discussion at a number of venues both within and outside of
NIH. Some common themes and recommendations emerged from these discussions.
These include 1) enhanced support of community-based research-driven
informatics technology development; 2) improved mechanism to support software
development throughout development lifecycles (prototyping, enhancement,
dissemination, and maintenance); 3) sustained effort to promote data sharing
and to improve software interoperability; 4) coordinated effort to establish
data exchange standards and common data elements; and 5) enhanced training in
bio-computing. These critical needs identified by the research community are
recognized by NCI and formed the basis in developing the NCI Informatics
Technology for Cancer Research (ITCR) Initiative, of which the current FOA is a
component that aims at supporting early-stage research-driven informatics
technology development.

Specific Research Objectives

This FOA encourages applications that involve the
development of innovative and user friendly informatics technologies of
significant value to the whole spectrum of cancer research from bench to
bedside. The emphasis will be on novelty, uniqueness, and potential impact to
the parent project and the broader cancer research field. Potential applicants
are advised to consult with the Scientific/Research Contact listed in Section VII. Agency Contacts.

The scope of this FOA is limited to informatics technology
development. Some
examples of the utility of informatics technologies that may be addressed in
response to this FOA include, but are not limited to, the following:

Examples
of research projects that are not appropriate for this FOA include the
following:

Applications that are research centric or focus on data
collection, data processing, data analysis, and computational modeling and
simulation without informatics technology development.

Development of technologies that are not computation or
informatics based.

Wet-lab based technology development is supported by the NCI
IMAT Program. Potential applicants who are interested in the development of
molecular technologies are advised to consult with scientific staff of the IMAT
Program for suitability of submission.

Program Priorities

As the goal of this FOA is to support the development of
enabling informatics technologies to enhance research of the parent grants,
program priorities will be given to applications that are exceptional in the
following aspects: 1) potential impact and utility, 2) the level of integration
between the technology component and the parent grant research component, 3)
the uniqueness of the proposed technology, and 4) proposed technology dissemination
plan. There are no limitations regarding the area of research of the parent
grant, but the performance of which will be a factor of consideration in making
funding recommendations. Funds requested must be used to support informatics
technology development instead of research.

This
FOA versus Alternative Opportunities

As listed below, there are four additional FOAs issued under
the ITCR Initiative that cover additional types of project and support
technology development at different stages. Investigators are allowed to submit
multiple applications in response to these FOAs given that they are
scientifically distinct from each other.

PAR-12-286, "Revisions for Early-Stage Development of
Informatics Technology (R01)";

PAR-12-289, "Revisions for Early-Stage Development of
Informatics Technology (U01)";

PAR-12-288, "Early-Stage Development of Informatics
Technology (U01)"; and

Applicants may request support for up to 2 years, not to
exceed the remaining number of years on the parent grant. If a no-cost
extension is needed on the parent grant, it must be in place before the
revision application is submitted.

NIH grants policies as
described in the NIH
Grants Policy Statement will apply
to the applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Applicant organizations must complete and maintain the
following registrations as described in the SF 424 (R&R) Application Guide
to be eligible to apply for or receive an award. All registrations must be
completed prior to the application being submitted. Registration can take 6
weeks or more, so applicants should begin the registration process as soon as
possible. The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.

Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
can begin both SAM and eRA Commons registrations. The same DUNS number must be
used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least
annually. The renewal process may require as much time as the initial
registration. SAM registration includes the assignment of a Commercial and
Government Entity (CAGE) Code for domestic organizations which have not already
been assigned a CAGE Code.

eRA Commons - Applicants
must have an active DUNS number and SAM registration in order to complete the
eRA Commons registration. Organizations can register with the eRA Commons as
they are working through their SAM or Grants.gov registration. eRA Commons
requires organizations to identify at least one Signing Official (SO) and at
least one Program Director/Principal Investigator (PD/PI) account in order to
submit an application.

Grants.gov – Applicants
must have an active DUNS number and SAM registration in order to complete the
Grants.gov registration.

Program
Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should
work with their organizational officials to either create a new account or to
affiliate an existing account with the applicant organization’s eRA Commons
account. If the PD/PI is also the organizational Signing Official, they must
have two distinct eRA Commons accounts, one for each role. Obtaining an eRA
Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the
same as one already reviewed within the past thirty-seven months (as described
in the NIH
Grants Policy Statement), except for submission:

To an RFA of an application that was submitted previously as an
investigator-initiated application but not paid;

Of an investigator-initiated application that was originally
submitted to an RFA but not paid; or

Of an application with a changed grant activity code.

Section IV. Application
and Submission Information

1. Requesting an
Application Package

Applicants can access the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and
submit applications through Grants.gov to NIH. Applications prepared and submitted
using applicant systems capable of submitting electronic multi-project
applications to Grants.gov will also be accepted.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise and where instructions in the
Application Guide are directly related to the Grants.gov downloadable forms
currently used with most NIH opportunities. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

Additional page limits described in the SF424 Application
Guide and the Table of
Page Limits must be followed.

Instructions for the Submission of Multi-Component
Applications

The following section supplements the instructions found in
the SF424 (R&R) Application Guide, and should be used for preparing a
multi-component application.

The application should consist of the following components:

Overall: required

Research Project: required

Overall Component

When preparing your application in ASSIST, use Component
Type ‘Overall’.

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other
components should be repeated in cell line table in Overall component.

Research & Related Other Project
Information (Overall)

Follow standard instructions.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

A
summary of Project/Performance Sites in the Overall section of the assembled
application image in eRA Commons compiled from data collected in the other
components will be generated upon submission.

Research & Related Senior/Key
Person Profile (Overall)

Include only the Project Director/Principal Investigator
(PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire
application.

A
summary of Senior/Key Persons followed by their Biographical Sketches in the
Overall section of the assembled application image in eRA Commons will be
generated upon submission.

Budget (Overall)

The only budget information included in the Overall
component is the Estimated Project Funding section of the SF424 (R&R)
Cover.

A
budget summary in the Overall section of the assembled application image in eRA
Commons compiled from detailed budget data collected in the other components
will be generated upon submission.

PHS 398 Research Plan (Overall)

Introduction
to Application: For Resubmission and Revision applications, an
Introduction to Application is required in the Overall component.

Specific
Aims: Outline the Specific Aims of the entire P01 Program
including the proposed new project.

Research
Strategy: The application should first state very concisely the
overall goals of the ongoing P01 and summarize the progress made in each funded
project and shared resource core. The application should contain sufficient
information about the ongoing program activities to permit an adequate
evaluation of the requested expansion of the overall P01. Provide the rationale
and justification for adding the proposed new project. Explain how it will
affect the overall theme, goals, objectives, aims, and research strategy of the
ongoing program. Include the relevance of the newly proposed research project
to the entire P01; and how the funds will influence the specific aims, research
design, and methods of the current grant.

In the Project Director/Principal Investigator section of the
form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.

In the
additional Senior/Key Profiles section, list Senior/Key persons that are
working in the component.

Include a
single Biographical Sketch for each Senior/Key person listed in the application
regardless of the number of components in which they participate. When a
Senior/Key person is listed in multiple components, the Biographical Sketch can
be included in any one component.

If more
than 100 Senior/Key persons are included in a component, the Additional Senior
Key Person attachments should be used.

Budget (Research Project)

Budget forms appropriate for the specific component will
be included in the application package.

Awardees of this FOA are required to attend annual
meetings of the ITCR to present progress of their projects. In the application,
a travel budget of one to two trips per year to go to these meetings should be included.

Note:
The R&R Budget form included in many of the component types allows for up
to 100 Senior/Key Persons in section A and 100 Equipment Items in section C
prior to using attachments for additional entries. All other SF424 (R&R)
instructions apply.

PHS 398 Research Plan (Research Project)

Introduction
to Application: For Resubmission and Revision applications, an
Introduction to the Application is allowed for each component

Specific
Aims: Outline the Specific Aims of the proposed new project.

Research
Strategy: The proposed projectsare expected to focus on early-stage
development of enabling informatics technologies to improve the acquisition,
management, analysis, and dissemination of data and knowledge. Address
rationale, significance, and approach of the proposed new project following the
standard guidelines for research strategy. Interdisciplinary collaborations in
the development of innovative computational methods and informatics approaches
that ultimately translate data into knowledge and clinical practice are
encouraged.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide, with the following modifications:

All applications, regardless of the amount of direct costs
requested for any one year, should address a Software Dissemination Plan.

Software
Dissemination Plan:

A software dissemination plan, with appropriate
timelines, is expected to be included in the Resource Sharing Plan(s) in the
PHS398 Specific Research Plan Component to meet the goals of this initiative.
Grantees are entitled to limited software copyright protections and institutional
software licensing agreements.

There is no prescribed single license for software
produced under this FOA; however reviewers will be instructed to evaluate
dissemination plans which should be consistent with the following guidelines:

The
software should be freely available to biomedical researchers and educators in
the non-profit sector, such as institutions of education, research
institutions, and government laboratories.

The terms
of software availability should include the ability of outside researchers to
modify the source code and to share modifications with other colleagues as well
as with the investigators. The terms should also permit the dissemination and
commercialization of enhanced or customized versions of the software, or
incorporation of the software or pieces of it into other software packages.

To
preserve utility to the community, the software should be transferable such
that another individual or team can continue development in the event that the
original investigators are unwilling or unable to do so.

Applicants
are expected to propose a plan to manage and disseminate the improvements or
customizations of their tools and resources that are contributed by others.
This proposal may include a plan to incorporate the enhancements into the
“official” core software, may involve the creation of an infrastructure for
plug-ins, or may describe some other solution.

One of the goals of this ITCR funding program is to
establish a repository of software developed under this program. Once implemented,
funded individual projects will be expected to deposit their software including
the source codes and documentations at the repository, allowing centralized
access and dissemination, consistent with achieving the goals of this program.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for
the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Research Project)

When conducting clinical research, follow all
instructions for completing Planned Enrollment Reports as described in the
SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion
Enrollment Report (Research Project)

When conducting clinical research, follow all
instructions for completing Cumulative Inclusion Enrollment Report as described
in the SF424 (R&R) Application Guide.

3. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications
before the due date to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants
across all Federal agencies) using ASSIST or other electronic submission
systems. Applicants must then complete the submission process by tracking the
status of the application in the eRA Commons, NIH’s electronic system for grants
administration.

Applicants
are responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.

Important
reminders:All PD(s)/PI(s) and component Project Leads must include their
eRA Commons ID in the Credential fieldof the Senior/Key Person Profile
Component of the SF424(R&R) Application Package. Failure to register
in the Commons and to include a valid PD/PI Commons ID in the credential field
will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management (SAM). Additional information
may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review, NIH. Applications that are
incomplete will not be reviewed.

Annual
Meeting

Awardees of this FOA are required to attend annual meetings
of the ITCR to present progress of their projects. To maximize the impact and
utility of technologies developed under the ITCR, awardees are encouraged to
interact and collaborate with each other in the effort to develop interoperable
software tools. Periodically, the ITCR may organize special workshops to discuss
emerging topics and issues in cancer informatics that require community
engagement and input. Awardees will be expected to participate in these
activities should they be called for.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-13-030,

Section V. Application
Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact - Overall

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
project proposed).

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

What will be the value of the proposed informatics
technology to the parent project and to the broader cancer research field? Does
it enable the parent project to propose new hypotheses, answer new questions,
extend the scope to new important areas, generate new knowledge, or allow the
project to be conducted with higher efficiency and productivity?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other
researchers well suited to the project? If Early Stage Investigators or New
Investigators, or in the early stages of independent careers, do they have
appropriate experience and training? If established, have they demonstrated an
ongoing record of accomplishments that have advanced their field(s)? If the
project is collaborative or multi-PD/PI, do the investigators have
complementary and integrated expertise; are their leadership approach, governance
and organizational structure appropriate for the project?

What is the track record of the investigator(s) in
technology innovation and dissemination?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?

How innovative is the proposed technology? Do similar
tools currently exist? What is the advantage of the new tool in comparison to
competing technologies?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented?
If the project is in the early stages of development, will the strategy
establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?

Is there enough flexibility built into the development
framework that allows the software to adapt continually to evolving new data,
technology, and user requirements, and allows it to be interoperable with other
related software tools? Are the proposed timeline and milestones sound and
realistic? How closely integrated are the research project(s) of the parent
grant and the informatics technology development project in the application?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements?

Additional Review Criteria - Overall

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give separate
scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Guidelines
for the Review of Human Subjects.

Inclusion of Women, Minorities, and
Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities
and members of both genders, as well as the inclusion of children. For
additional information on review of the Inclusion section, please refer to the Guidelines
for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the
application as currently presented, taking into consideration the responses to
the previous review and changes made to the project.

Renewals

Not Applicable.

Revisions

For Revisions, the committee will consider the
appropriateness of the proposed expansion of the scope of the project. If the
Revision application relates to a specific line of investigation presented in
the original application that was not recommended for approval by the committee,
then the committee will consider whether the responses to comments from the
previous scientific review group are adequate and whether substantial changes
are clearly evident.

Additional Review Considerations - Overall

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these
items, and should not consider them in providing an overall impact score.

Applications from Foreign
Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor possession
use and transfer of Select Agent(s), and 4) plans for appropriate biosafety,
biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by the NCI, in accordance with NIH
peer review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact
score.

Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications
will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications
will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

When multiple years are involved, awardees will be required
to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR)
annually and financial statements as required in the NIH
Grants Policy Statement.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH
Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH
Grants Policy Statement for additional information on this reporting
requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.